FDA OKs New Dosage Strength of Buprenorphine and Naloxone Sublingual Film

Officials with the FDA have approved a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film (Cassipa, Teva Pharmaceuticals) for the maintenance treatment of opioid dependence. The combination also is approved by the agency for both brand name and generic versions, and in various strengths.

In a prepared statement, FDA Commissioner Scott Gottlieb, MD, said the agency recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment, he added.

“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder. The introduction of new treatment options has the potential to broaden access for patients,” said Gottlieb, in the prepared statement. “The FDA is committed to helping those with opioid use disorder transition to lives of sobriety. We’ve taken a number of steps to advance the development of new FDA-approved treatments for opioid dependence and encourage health care professionals to ensure patients are offered an adequate chance to benefit from these therapies.”

According to Gottlieb, individuals who successfully transition onto medication-assisted treatment are not swapping 1 addiction for another. Rather, he said, the prepared statement, opioid replacement therapy can be an important part of effective treatment. “Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication,”” Gottlieb added.

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